FDA WARNING_LETTER - Entrenet Nutritionals, Inc. - November 01, 2012

The FDA issued a Warning Letter to Entrenet Nutritionals, Inc. following an October-November 2012 inspection, citing serious violations of dietary supplement CGMP regulations (21 CFR Part 111) and misbranding. Products were deemed adulterated and, in some cases, unapproved new drugs. Specific products (Gone, Cardio Rescue, Arthri-Attack, Complete Food Supreme) were classified as unapproved new drugs due to therapeutic claims on their labels, such as reducing pain or supporting cardiovascular health. Cardio Rescue and Complete Food Supreme were also misbranded for lacking adequate directions for use. CGMP violations included the failure to establish and follow written procedures for quality control operations (material review, disposition, product release), product complaint review and record-keeping, holding and distributing, and handling returned dietary supplements. The FDA emphasized the firm's ultimate responsibility for CGMP compliance as a distributor. Extensive dietary supplement misbranding violations (21 CFR Part 101) affected numerous products, including failures related to product identification as "dietary supplement," "Supplement Facts" labeling, ingredient representation (e.g., Siberian Ginseng), identification of botanical plant parts, serving size, number of servings, name/place of business, net quantity of contents, and adverse event reporting contact information. Entrenet Nutritionals must promptly correct all violations and respond within fifteen working days with detailed corrective actions and a timeline. Non-compliance could lead to regulatory actions like injunction or seizure, and reinspection fees.